BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover...
FDA Recall #Z-0738-2013 — Class II — December 25, 2012
Product Description
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Reason for Recall
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Recalling Firm
bioMerieux, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1690 cases
Distribution
Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
Code Information
Catalog Number: 259789, Lots/Batch: 1031866
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated